Clinical and Regulatory Services

One-Stop-Shop for Your Clinical, Regulatory, and Quality Compliance Solutions

Achieve State-of-the-Art Compliance for Your Medical Device Regulatory Requirement

Our Services

PMCF Survey Execution for EU MDR compliance

PMCF plan
PMCF survey plan including statistical analysis plan
Survey questionnaire
PMCF data collection using EU regulators approved and GDPR compliant High-Quality Surveys
Statistical Analysis
PMCF Survey report
PMCF Evaluation report
NB Liaison

EU MDD to EU MDR transition

Summary of Technical Documentation Preparation
Gap assessment for Clinical Evaluation Plan and Clinical Evaluation Report, and Literature Review
Updating PMS with the PMS Plan, PMSR (Only for Class I), PSUR, PMCF Plan, and PMCF report
Updating the 13485 procedures as per MDR

Clinical Strategy/Support

Clinical Strategy & Consulting
Clinical Investigation Plan (CIP)/Investigator Brochure (IB) preparation
Clinical Literature Reviews
Clinical Writing (CEP/CER, and SSCP)
Clinical Risk-Benefit Analysis
Promotional Materials Review and Claims Management

Clinical Literature Review

Clinical Strategy & Consulting
Clinical Investigation Plan (CIP)/Investigator Brochure (IB) preparation
Clinical Literature Reviews
Clinical Writing (CEP/CER, and SSCP)
Clinical Risk-Benefit Analysis
Promotional Materials Review and Claims Management

EU MDD Support

STED preparation
Updating PMS with the PMS Plan, PMSR (Only for Class I), PSUR, PMCF Plan, and PMCF report PMS
Updating the CER for MDD certificate renewal

Regulatory Strategy / Support

Strategic Regulatory Consulting
Regulatory Operations Support
Document Management, Publishing, Maintenance
IFU and Label Management
Market Approval (EU and Other Regions)
Regulatory Support – Software as a Medical Device (SaMD)

QMS Strategy / Support

Procedures, Work Instructions, SOPs, Templates creation
QMS Transformation – EU MDR Compliance
Product Risk Management and Risk Evaluation Files

PMS Strategy / Support

Complaint Handling; Adverse Event Reporting
Post Market Surveillance Reports (PMSR), Post Market Surveillance Update Reports (PSUR) Preparation
Post Market Clinical Follow-up (PMCF) Plan/Report
PMCF Surveys Plan/Report

Our Regulatory and Clinical Services Team Leads

Rachel Derksen

Prem Pandey

Rachel Derksen

Prem Pandey

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